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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05451004
Other study ID # CCTG-HN11
Secondary ID CCTG-HN11NCI-202
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 10, 2023
Est. completion date August 30, 2031

Study information

Verified date March 2024
Source Canadian Cancer Trials Group
Contact Wendy Parulekar
Phone 613-533-6430
Email wparulekar@ctg.queensu.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is being done to answer the following question: Is the chance of cancer spreading or returning the same if radiotherapy to the neck is guided, by using a special imaging study called lymph node mapping (lymphatic mapping) Single Photon Emission Computed Tomography (SPECT-CT), compared to the usual treatment when radiotherapy is given to both sides of the neck?


Description:

This study is being conducted in order to find out if this approach is as good as the usual approach in controlling the cancer and has fewer side effects and better quality of life. The usual approach for patients who are not in a study is treatment which includes radiotherapy to the tumour and to both sides of the neck to decrease the risk of spread or recurrence of the cancer


Recruitment information / eligibility

Status Recruiting
Enrollment 510
Est. completion date August 30, 2031
Est. primary completion date August 30, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with pathologically proven diagnosis of lateralized OPC (tonsil, tongue base, soft palate, or pharyngeal wall) not involving or crossing midline. - HPV positive or negative (by p16 immunohistochemistry). - Clinical stage T1-3 M0 (UICC/AJCC TNM 8th Edition). Nodal involvement may include no nodes or single or multiple ipsilateral lymph nodes (largest =6cm in maximum diameter) - Radiological investigations within 8 weeks of registration: - CT or MRI of the neck (with head imaging as indicated); - PET-CT scan - Chest CT scan - Planned definitive RT or CRT with bilateral neck RT (patients planned for unilateral neck RT are excluded). - Intent to deliver concurrent chemotherapy or not must be known at the time of randomization. As this is a pragmatic trial, even patients who are not candidates for systemic therapy will be eligible for participation. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. - Willing to complete the quality of life and/or health utility questionnaire, if sufficiently fluent in available language(s). - Informed consent prior to registration - Accessible for treatment and follow-up. - Commencement of definitive RT within 28 days (+ 14 days) of randomization. - Injection procedure for lymphatic mapping may be performed in the nuclear medicine, ambulatory clinic, or operating room setting - Women/men of childbearing potential must have agreed to use a highly effective contraceptive method - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. - Patient must consent to provision of, and investigator(s) must confirm location and commitment to obtain a representation of formalin fixed paraffin block of non-cytology tumour tissue in order that the specific correlative marker assays Exclusion Criteria: - T1-T2 cancers isolated to the tonsil fossa (i.e. without any soft palate, tongue base, posterior pharyngeal wall or posterior tonsil pillar involvement) with no involved lymph nodes or with a single ipsilateral node < 3 cm without extranodal extension. - Tonsil or tongue base primary cancer who have previously undergone diagnostic palatine or lingual tonsillectomy with either complete excision or with no clinically apparent residual disease - Previous head and neck cancer or multiple synchronous primary head and neck cancers - Previous induction or neo-adjuvant chemotherapy. - Previous radiation therapy to the head and neck or comprehensive neck dissection of at least 3 levels on either side (due to potential for disrupted lymphatic channels and drainage pathways). Patients who have had excisional biopsies of involved lymph nodes are eligible - Radiotracer allergy - Severe, active co-morbidity including any of the following: - Chronic Obstructive Pulmonary Disease or other pulmonary illness requiring hospitalization within 30 days of registration - Unstable angina and/or congestive heart failure requiring hospitalization within the 30 days of registration - Acute myocardial infarction within 30 days of study registration - Diseases precluding RT (e.g. scleroderma)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Lymphatic Mapping with SPECT-CT
Radiation: Ipsilateral Neck Radiotherapy and SPECT-CT Guided Contralateral Neck Radiotherapy
Radiation:
Ipsilateral and Contralateral Neck
Radiotherapy

Locations

Country Name City State
Canada Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke Quebec
Canada Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto Ontario
Canada University Health Network-Princess Margaret Hospital Toronto Ontario
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Emory University Hospital Midtown Atlanta Georgia
United States University of Michigan - Brighton Center for Specialty Care Brighton Michigan
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Northwestern University Chicago Illinois
United States MD Anderson in The Woodlands Conroe Texas
United States M D Anderson Cancer Center Houston Texas
United States MD Anderson West Houston Houston Texas
United States Baptist MD Anderson Cancer Center Jacksonville Florida
United States MD Anderson League City League City Texas
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Providence Portland Medical Center Portland Oregon
United States MD Anderson in Sugar Land Sugar Land Texas
United States Moffitt Cancer Center Tampa Florida
United States Moffitt Cancer Center - McKinley Campus Tampa Florida
United States Moffitt Cancer Center-International Plaza Tampa Florida
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois

Sponsors (5)

Lead Sponsor Collaborator
Canadian Cancer Trials Group Alliance for Clinical Trials in Oncology, Eastern Cooperative Oncology Group, NRG Oncology, SWOG Cancer Research Network

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease-free Survival 8 years
Secondary Quality of Life using M.D. Anderson Dysphagia Inventory (MDADI) Possible range of scores between 0 and 100 (higher scores indicating better swallowing and lower score indicating poor swallowing). 8 years
Secondary Xerostomia-related Quality of Life using Xerostomia Questionnaire (XQ) Clinically meaningful worsening of xerostomia (10 units on XQ) from baseline to 12 months post RT 8 years
Secondary Isolated contralateral neck failure (iCNF) 8 years
Secondary Overall Survival (OS) 8 years
Secondary Logo-regional Failure (LRF) 8 years
Secondary Distant Metastases (DM) 8 years
Secondary Incidence and Severity of Radiation-related Toxicities 8 years
Secondary Patient-Reported Toxicities using PRO CTCAE 8 years
Secondary Gastrostomy Tube Usage 8 years
Secondary Resource Utilization 8 years
Secondary Lost Productivity Healthcare system and societal resources will be quantified over the course of the trial to generate utilization information by patient in each study arm. We will generate an average cost per study subject by treatment arm for an overall mean cost per study arm 8 years
Secondary Financial Toxicity [Financial Index of Toxicity (FIT)] 8 years
Secondary Health Utilities using EQ-5D 8 years
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